Current methods to limit the number of uses of electrical devices, such as those used in surgical procedures or other health or medical related applications have relied upon regulatory actions, such as regulations promulgated by the United Stated FDA and the European Regulatory body (EUR). Clearly, this method relies upon the user to adhere to those regulations subject to penalties for non-compliance. Thus, this is only a self-adhering method to limit the use of these devices.
Minimally invasive surgical devices comprise most of the electrical devices whose use is limited by regulatory action. These devices can be expensive and reimbursement for their use can be tightly controlled by health insurance. Further, in many parts of the lesser-developed countries of the world, availability can be limited. These devices are regulated to limit the amount of usage because of efficacy, sterility, and to limit cross contamination etc. Within the US, tracking of the devices by lot and serial number is required in the entire distribution channel to the end use. The tracking system, along with the threat of lawsuit, creates a barrier to misuse. However, outside of the US where the tort system is not as well developed, multiple misuses can occur with greater frequency. These factors present a potential liability for the manufacturer of these devices along with the associated tarnishing of goodwill and reputation to the manufacturer.
Another prior art method has been the implementation of electrical circuits with associated electronic integrated circuits, and associated software to limit the use of the device. This “solution” has at least two limitations. First, they cannot be used to retrofit existing devices easily. Since such devices must work with an electronic controller that manages the device, the retrofitting of the existing devices may necessitate a retrofit of the controller. Second, one of the most effective method of sterilizing these devices is through the use of gamma radiation (or x-ray). X rays potentially can destroy integrated circuits and/or alter the content of memory and integrated circuits, thereby altering the software in an uncontrollable manner.
Hence, there is a need for a limiter switch that can be used in a surgical or medical device to limit the amount of uses of such devices that is both easy to use and is immune to most sterilization techniques, and is stable in all known forms of sterilization, e.g. Gamma, ETO, E-Beam, AutoClave, etc.